Training LeafletNCT01998373
Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
A study testing training leaflet and oral training in people with Training Leaflet and Training Workshop, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Abstract Background: It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 34 to 60 years
- Conditions the study is for
- Training Leaflet, Training Workshop
- What is being tested?
- training leaflet and oral training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease).
Who cannot join
- Patients were excluded if they had another disease.
Trial locations and contacts
1 site in 1 country.
Iran1 site
the rheumatology clinic at Imam Khomeini Hospital in Tehran
Tehran, Tehran Province
About this study
Official title: The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Abstract
Background:
Read more
It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients.
Methods:
Patients were allocated to a patient training intervention group and patient without training intervention group. Both groups received routine treatments while the patient training intervention group, in addition to the routine treatments received training booklets and participated in the training workshop. All the extracted data from the written questionnaire were collected and analyzed using SPSS software.
Read the detailed description
Results:
The improvement in the signs of recovery for physical and mood symptoms in the patient training intervention group were seen (p < 0.05). The score of quality of life had significantly improved in the two groups (Mean difference was 9.31±3.03 and P<0.003). This improvement was significantly higher in the patient training intervention group (P=0.008). After adjustment for education level, the score of quality of life in patient training intervention group had a higher improvement, but the difference between the two groups was not significant (P = 0.1).
Conclusions:
This study showed the important role of training and the patients' educational level on better treatments. The appropriate training in the patient could create a change in the treatment process and has a better effect on quality of life.
- Conditions
- Training Leaflet, Training Workshop
- Being tested
- training leaflet and oral training
- Keywords
- Patient training, Rheumatoid arthritis, Quality of life
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training leaflet and oral trainingBehavioural
Also called education, training workshop
The intervention consisted of training leaflet and oral training. All of the patients were new cases and were divided into 2 groups. All patients were treated with routine medication, no addition medication for two groups were done, the case group attended the workshops and were trained In addition to medical therapy, continuing education and training workshop. The result of the effect of workshop was also filling out a questionnaire before and after training. Finally, two groups with statistical analysis were compared.
| Study group | Role | What they receive |
|---|---|---|
| patient training and patient without training | Experimental | Experimental group 1: patient education intervention group (PIGE) Experimental group 2: patient without intervention group (PWIG) Receives: Behavioral: training leaflet and oral training |
| control without education | No intervention | this group did not receive an education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of quality of life had significantly improved in the two groups (using questionnaire)
Measured: one year
Secondary outcomes (1)
In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training LeafletStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Khazaeipour, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998373
- Sponsor's protocol ID
- 7971
- Status last verified
- Nov 2013
- First submitted
- 18 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01998373
- Acronym / sponsor ID
- 7971
- Conditions
- Training Leaflet, Training Workshop
- Keywords
- Patient training, Rheumatoid arthritis, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract
Background:
It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients.
Methods:
Patients were allocated to a patient training intervention group and patient without training intervention group. Both groups received routine treatments while the patient training intervention group, in addition to the routine treatments received training booklets and participated in the training workshop. All the extracted data from the written questionnaire were collected and analyzed using SPSS software.
Detailed description
Results:
The improvement in the signs of recovery for physical and mood symptoms in the patient training intervention group were seen (p < 0.05). The score of quality of life had significantly improved in the two groups (Mean difference was 9.31±3.03 and P<0.003). This improvement was significantly higher in the patient training intervention group (P=0.008). After adjustment for education level, the score of quality of life in patient training intervention group had a higher improvement, but the difference between the two groups was not significant (P = 0.1).
Conclusions:
This study showed the important role of training and the patients' educational level on better treatments. The appropriate training in the patient could create a change in the treatment process and has a better effect on quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient training and patient without training | Experimental | Behavioral: training leaflet and oral trainingExperimental group 1: patient education intervention group (PIGE) Experimental group 2: patient without intervention group (PWIG) |
| control without education | No intervention | –this group did not receive an education |
Who may qualify
- Ages
- 34 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease).
Key exclusion criteria (1 listed)
- Patients were excluded if they had another disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training leaflet and oral trainingAlso: education, training workshopThe intervention consisted of training leaflet and oral training. All of the patients were new cases and were divided into 2 groups. All patients were treated with routine medication, no addition medication for two groups were done, the case group attended the workshops and were trained In addition to medical therapy, continuing education and training workshop. The result of the effect of workshop was also filling out a questionnaire before and after training. Finally, two groups with statistical analysis were compared. | Behavioural | patient training and patient without training |
Primary outcome
The score of quality of life had significantly improved in the two groups (using questionnaire)
Time frame: one year
1 secondary outcome
In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training leaflet and oral training in people with Training Leaflet and Training Workshop, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of quality of life had significantly improved in the two groups (using questionnaire) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.